Glecaprevir/Pibrentasvir

Dosing

DurationNo renal dose adjustment3 tablets once daily (1 tablet = Glecaprevir 100 mg/Pibrentasvir 40 mg)

  • Take with food- Genotype 1-6, treatment-naïve, non-cirrhotic: 8 weeks

  • Genotype 1-6, treatment-naïve, compensated cirrhotic: 12 weeks (국내허가사항: 8주)

  • Genotype 1, previously treated with NS5A inhibitor, not previously treated with NS3/4a protease inhibitor, compensated cirrhotic/non-cirrhotic: 16 weeks

  • Genotype 1, previously treated with NS3/4a protease inhibitor, not previously treated with NS5A inhibitor, compensated cirrhotic/non-cirrhotic: 12 weeks

  • Genotype 1, 2, 4-6, previously treated with interferon, ribavirin, or sofosbuvir, no previous experience with NS5A or NS3/4A inhibitor, non-cirrhotic: 8 weeks

  • Genotype 1, 2, 4-6, previously treated with interferon, ribavirin, or sofosbuvir, no previous experience with NS5A or NS3/4A inhibitor, compensated cirrhotic: 12 weeks

  • Genotype 3, previously treated with interferon, ribavirin, or sofosbuvir, no previous experience with NS5A or NS3/4A inhibitor, compensated cirrhotic/non-cirrhotic: 16 weeks

Age 12-17y, BW ≥45 kgNo renal dose adjustment3 tablets once daily (1 tablet = Glecaprevir 100 mg/Pibrentasvir 40 mg)

  • Take with food

  • Look at adult dosing for duration of treatment

Mild hepatic impairmentModerate or severe hepatic impairmentNo dose adjustmentUse is contraindicated

General Information

Hepatitis C, chronic, Genotype 1, 2, 3, 4, 5, and 6.

Black Box Warning: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Test for hepatitis B surface antigen and hepatitis B core antibody prior to initiation.

Monitor signs and symptoms of hepatitis flare or HBV reactivation during treatment and post-treatment follow-up in patients with evidence of current or prior HBV infection.

Monitor hepatic function at baseline and during treatment.

Common

  • Nausea

  • Headache

  • Fatigue

Severe

  • Liver failure

  • Decrease in liver function

  • Reactivation of HBV

Contraindication:

  • Rifampin

  • Atazanavir

Major drug-drug interactions:

  • Lopinavir

  • Ritonavir

  • Darunavir

  • Carbamazepine

  • Atorvastatin

  • Simvastatin

  • Lovastatin

  • Cyclosporine

  • Efavirenz

  • Capmatinib

  • Phenytoin

  • St. John's wort

  • Ethinyl estradiol

  • Venetoclax

Antimicrobial class: Antiviral agent, HCV NS5A inhibitor (Pibrentasvir), HCV NS3/4A Protease Inhibitor (Glecaprevir)

Average serum half life: 6 hours (Glecaprevir), 13 hours (Pibrentasvir)

Precautions: Monitoring recommended and discontinuation may be necessary in cases of hepatic decompensation/failure without cirrhosis or with compensated cirrhosis, patients taking concomitant medications, or with confounding factors (e.g. liver-related medical or surgical comorbidities).

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